United States of America. The Food and Drug Administration has issued a final rule to provide new, easy-to-understand labelling on nonprescription (OTC) drugs.

The regulation calls for a standardized format that will improve the labelling on the most-used drugs: nonprescription or over- the-counter (OTC) drugs. By clearly showing a drug’s ingredients (including inactive ingredients), dose and warnings, the new labelling will make it easier for consumers to understand information about a drug’s benefits and risks and about the proper use of the drug.

The FDA recommends that manufacturers include a phone number that consumers can call for more information or for answers to their questions. The rule also sets minimum type sizes and standards for other graphic features for the standardized format.

References:

1) HHS News P98-7, dated 11 March 1999
2) Federal Register 64(51): 13253-13302 (1999).